Database updated: 27 October 2026
Safety Information
Medsafe Online Recall Database
Detail of Recall
| Type of Product: | Device |
| Medsafe Reference: | 36676 |
| Brand Name: | Atellica CH Creatine Kinase |
| Model: | Serial number - 11097640 |
| Affected: | Lot numbers - 252591, 252602, 252612 |
| Software version: | |
| Recalling Organisation: | Siemens Healthcare (NZ) Ltd Millennium Centre, Part Level 2, Building A 600 Great South Road Ellerslie AUCKLAND 1051 |
| Contact Information: | 0800 310 300 |
| Manufacturer: | Siemens Healthcare Diagnostics Inc |
| Issue: | The manufacturer has confirmed, through investigation of customer complaints, the potential for falsely elevated patient, quality control (QC), and/or calibrator results when using Atellica CH Creatine Kinase (CK_L) lot numbers 252591, 252602 and 252612 on the Atellica CH and Atellica CI Analyzers. This problem may be observed with both serum and plasma sample types. QC results may or may not detect the problem. the manufacturer is actively investigating the root cause of this problem. |
| Recall action type: | Recall |
| Recall action: | Product to be destroyed |
| Level of recall: | Hospital/Pharmacy/Laboratory |
| Date Commenced: | 20/3/2026 |
